Study Summary
This trial will look at whether or not teaching people with obesity about the primitive brain and how to create a safe environment will help with weight loss, psychiatric symptoms, eating behaviors, sleep, activity level, and quality of life.
Eligible Conditions
- Overweight and Obesity
- Eating Disorders
- Depression and Anxiety
Treatment Effectiveness
Effectiveness Progress
Study Objectives
13 Primary · 24 Secondary · Reporting Duration: 4 weeks after starting intervention
Week 4
Patient satisfaction score
Week 4
Study components feedback score at 4 weeks after starting intervention
Week 8
Study components feedback score at 8 weeks after starting intervention
Week 4
Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 1
Change in Behavioral Patterns from Pre-assessment to Post-assessment 1
Change in Mental Health Summary Scores from Pre-assessment to Post-assessment 1
Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 1
Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 1
Change in activity score from Pre-assessment to Post-assessment 1
Change in anxiety score from Pre-assessment to Post-assessment 1
Change in depression score from Pre-assessment to Post-assessment 1
Change in eating pattern score from Pre-assessment to Post-assessment 1
Change in fatigue score from Pre-assessment to Post-assessment 1
Change in frequency of patients with eating disorders from Pre- assessment to Post-assessment 1
Pain
Change in physical function score from Pre-assessment to Post-assessment 1
Change in self-efficacy score from Pre-assessment to Post-assessment 1
Change in sleep disturbance score from Pre-assessment to Post-assessment 1
Change in sleep pattern score from Pre-assessment to Post-assessment 1
Change in weight from Pre-assessment to Post-assessment 1
Month 5
Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 2
Change in activity score from Pre-assessment to Post-assessment 2
Change in eating pattern score from Pre-assessment to Post-assessment 2
Change in sleep pattern score from Pre-assessment to Post-assessment 2
Month 5
Change in Mental Health Summary Scores from Pre-assessment to Post-assessment 2
Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 2
Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 2
Change in anxiety score from Pre-assessment to Post-assessment 2
Change in depression score from Pre-assessment to Post-assessment 2
Change in fatigue score from Pre-assessment to Post-assessment 2
Change in frequency of patients with eating disorders from Pre- assessment to Post-assessment 2
Change in pain interference score from Pre-assessment to Post-assessment 2
Change in physical function score from Pre-assessment to Post-assessment 2
Change in self-efficacy score from Pre-assessment to Post-assessment 2
Change in sleep disturbance score from Pre-assessment to Post-assessment 2
Change in weight from Pre-assessment to Post-assessment 2
Month 5
Change in Behavioral Patterns from Pre-assessment to Post-assessment 2
Trial Safety
Trial Design
1 Treatment Group
PsychoEd
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: Wellness Education · No Placebo Group · N/A
PsychoEd
Behavioral
Experimental Group · 1 Intervention: Wellness Education · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Wellness Education
2020
N/A
~1060
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks after starting intervention
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
953 Previous Clinical Trials
608,642 Total Patients Enrolled
1 Trials studying Overweight and Obesity
2,803 Patients Enrolled for Overweight and Obesity
Carrie J McAdams, MD PhDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
Eligibility Criteria
Age 18 - 70 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are able to understand study procedures, provide written informed consent for study participation, and complete questionnaires.
You are an outpatient.
Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| UT Southwestern Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments